MDT AutoSave is part of the change control and audit infrastructure that ensures manufacturers that processes have not been altered without approval or documentation. AutoSave's unique change control features, including internal security capabilities, have long been beneficial to regulated industry sites in meeting the requirements of the FDA, including compliance with 21 CFR 11. The AutoSave Approval and Audit Modules were developed to augment AutoSave's existing device program and document modules with the following advanced workflow and approval functionality:

Electronic approvals: approval groups can be easily configured via drag-and-drop interface allowing users to be assigned to one or many devices or documents; automatic capture of audit trail information including the approver's user ID and comments, activity date and time stamp; complete revision history and in-process status of active development projects available on-demand.

Multiple review statuses: view program versions that are in different statuses (request for approval, test, validate, implemented); complete history of review and approvals.

"The AutoSave Approval & Audit Trail Modules further demonstrate MDT's commitment to enable manufacturers to gain control of escalating automation challenges and ease change control burdens by securing software assets, reducing time and problems related to changes and complying with regulatory requirements for audit trails and change authorization," says Gary Gillespie, vice president and general manager of MDT software.

The MDT AutoSave Reports Module is included with the AutoSave Approval & Audit Trail Modules to provide greater exposure to changes in the automation layer. The AutoSave Reports Module allows users to generate more than 70 reports from the historical data stored in AutoSave. Users can filter data to specific information such as client, agent or user, create specialized audit reports and view important program statistics.www.mdt-software.com